Guidant has been forced to suspend supplies of its Xience V drug-eluting stent after uncovering manufacturing problems that affected around 1% of the product’s inventory.
The company, which is being acquired by Boston Scientific in a $27 billion deal, said it would take a charge of around $15 million in the first quarter as a result of the move. The problems are not expected to affect this transaction, or the related $4.1 billion purchase of Guidant’s stent business by Abbott Laboratories.
Xience V (everolimus) was approved in Europe in January and was due to be introduced in the second quarter of this year, although Guidant now says this will take place in the third quarter.
The stent is still in a registration trial called SPIRIT III in the USA and Japan, and enrollment of patients into this study will also be suspended while the manufacturing problems are sorted out.
The suspension is another piece of bad news for Guidant, which has been hit hard by a major recall of pacemaker and defibrillator products last summer that wreaked havoc with its revenues in the latter half of the year.
But the company said the suspension was temporary and supplies would resume – both for clinical trials and European market supply - once new inventory had been manufactured.
At the moment, the market for cardiovascular drug-eluting stents is split between Johnson & Johnson with its Cypher (sirolimus) product and Boston Scientific with Taxus (paclitaxel), which will benefit from the delay in competition from Xience V.